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The emphasis on validation had begun in 2002 with the advent of the Microbial Sampling of Ready-To-Eat Products for the FSIS Verification Testing program, the subsequent revisions in June 2003 with 9 CFR Part 430. Then on March 15, 2006 with the alternative control measures coupled with the EIAOs and a new type of risk based sampling programs for Lm for food contact and environmental surfaces.

Also, due to the requirements by the newly established Food Safety Modernization Act (FSMA) enacted into law by Congress in early 2012, a number of market sectors have already have mandated enforcement including validations using hygiene monitoring technologies.

The rise in implementation of the Global Food Safety Initiative (GFSI) programs, especially in the latest GFSI-approved versions of SQF, BRC, and now FSSC 22000 here in North America, has made validation mandatory via the various hygiene monitoring modalities.

Particularly, the new SQF edition 7 has an increased emphasis on Validation-Verification of hygiene monitoring/sanitation in module 11 and in module 12 as well as “mandatory elements.” This includes documented and frequency for validation of chemical concentrations and procedures (SSOPs) as well as the food contact and environmental surface hygiene monitoring validation methods and procedures.

Similarly, with the new BRC Issue 6, there is this enhanced enforcement on Validation-Verification in Clause 4.11.4 in Housekeeping & Hygiene. The Housekeeping & Hygiene clause is also considered a Fundamental Clause. Also, 4.9.1 emphasizes Chemical & Physical Contamination Control.

Zone Sampling Considerations

In both food processing plants as well as food service operations, many food safety experts and knowledgeable sanitarians view pre-requisite program controls as a multi-barrier system akin to a dartboard. We all know the Zone 1 or “bull’s eye” is the actual food contact zone. Obviously, all hygiene control programs must prevent pathogens and spoilage microbes from compromising this critical zone.

However, the sound proactive approach is to establish and maintain microbial control outward from Zone 2, which are the indirect food contact areas, to Zone 3, the immediate environmental zones around the food processing area, finally to the Zone 4 area that is the general environmental environs of the food plant. The objective of any sound hygiene monitoring program is to not merely focus on the bull’s eye, but be as assiduous in your program as you can to control Zones 4 and 3, thereby minimizing the risk upon Zones 2 and 1.

Therefore your hygiene monitoring validation programs must include both the Food Contact (Zones 1 and 2) and Environmental (Zones 3 and 4) for soil removal, as well as indicator and pathogen microbe validations. The frequencies will of course vary based upon the risk assessment of the plant’s HACCP program for each and every product manufactured at a specific plant site.

For example, on a post kill/cooked-RTE processing piece of direct food contact equipment, the frequency that equipment unit will be assayed on a weekly basis will be far greater than a raw meat blender or mixer under the hygiene sampling plan for that facility.

The selection of sites either during a pre-operational sampling or during a scheduled shift cleanup or even operational assessments must be selected based upon a program’s risk assessment of each site, but must be selected by the sampling team in a manner not to tip off the sanitation staff. The sampling matrix in its entirety must cover all critical food contact and environmental sites within the program’s mandated frequency. This is vital in order to generate a validation history that accurately reflects the realities of the facility’s design and operation.

Methodologies

There are a myriad of systems and devices to assess hygiene levels on both food contact and environmental surfaces. Some employ sophisticated microbial detection methods utilizing polymerase chain reaction (PCR) with sophisticated instrumentation. However, I will focus on some of these companies that have both soil detection, indicator microbial detection, and pathogen detection systems that are designed for hygiene monitoring programs in concert with plant sanitation.

Food Quality & Safety (formerly Food Quality) is the established authority in delivering strategic and tactical approaches necessary for quality assurance, safety, and security in the food and beverage industry.